US FDA Rescinds Market Denial Order For Juul Products

By Reuters
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US FDA Rescinds Market Denial Order For Juul Products

The US Food and Drug Administration (FDA) said it was rescinding a June 2022 order that briefly blocked sale of Juul's products, including its device for e-cigarettes.

The latest move comes a few months after Juul sought an FDA authorisation for new menthol-flavoured pods meant to be used with its e-cigarettes device, which was under the agency's review. Altria Group is a former investor of the company.

The FDA had banned Juul's four varieties of tobacco and menthol-flavoured pods and the e-cigarette device after it concluded that the company failed to show that sale of these products would be appropriate for public health.

The ban was stayed a month after it was issued as a result of an appeal by the company.

The FDA said rescission of orders that prevent marketing of the products is not an authorisation or a denial of Juul's marketing application. The revocation only returns company's applications to a pending and under-review status.


Multiple Challenges

The marketing denial orders issued by the FDA have faced multiple challenges in different US states by the e-cigarette makers.

"Some of these court decisions establish new case law and inform the FDA's approach to product review," the FDA said.

The agency began regulating e-cigarette devices and vapes in August 2016. So far, 23 e-cigarette products have been authorised by it for sale in the United States.

The FDA said continued review of Juul's application does not alter the fact that all e-cigarette products need its authorisation to be legally marketed.

Read More: Juul Plans To Lay Off 30% Of Workforce In Cost-Cut Push, Source Says

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